Intraocular lens spacer for cataract surgery

ABSTRACT

A device for maintaining the normal depth of a posterior chamber of the eye. One or more spacers are implantation in the lens capsule of a patient at a position anterior to an implanted posterior intraocular lens following removal of the natural crystalline lens. The spacer or at least one spacer has an outer diameter approximating the diameter of the lens capsule prior to removal of the crystalline lens. The one or more spacers in combination with the intraocular lens produce a depth for the lens capsule approximating the depth of the lens capsule prior to removal of said crystalline lens. The one or more spacers may be configured to prevent epithelial cell migration.

The invention is directed to the use of one or more spacers to be placedanterior to an intraocular lens (IOL), both the spacer and IOL beingwithin the lens capsule, of an aphakic individual. The spacers areuseful during any cataract surgery but maybe particularly beneficialwhen the patient is a high myope.

BACKGROUND

The human eye comprises a spherical structure that includes a cornea,which comprises the outer surface of the eye, a crystalline lenscentrally located in a lens capsule behind a pupil and retina, optic andother nerves on the rear wall of the eye. These nerves connect the eyesto the brain, and particular areas of the brain that are in neuralcommunication with the eyes. Images pass through the cornea and a pupil,which is centrally located in the iris, and are focused by the lens ontothe image receptors at the rear of the eye.

Each eye forms an image upon a vast array of light sensitivephotoreceptors of the retina. The outer cover of the eye, or cornea,protects the lens and acts as a colorless filter to refract light ontothe iris and pupil. The iris corresponds to the aperture in a camera andcontains muscles that alter the size of the pupil to control the amountof light that enters the eye. The natural crystalline lens locatedposterior to the pupil has a variable shape under the indirect controlof peripheral ciliary muscles. Having a refractive index higher than thesurrounding media, the crystalline lens gives the eye a variable focallength, allowing accommodation to objects at varying distances from theeye. Much of the remainder of the eye is filled with fluids underpressure that help the eye maintain its shape.

The human eye is susceptible to numerous disorders, diseases and opticaldeficiencies. Corrective glasses, contact lenses or laser sculptingtypically addresses optical deficiencies. Besides optical deficiencies,several diseases that can affect the natural crystalline lens or theoptical nerve or macula can degrade vision. For example, cataractsinterfere with vision by causing a cloudy or opaque discoloration of thenatural lens of the eye. Cataracts often result in partial or completeblindness. If this is the case, the crystalline lens can be removed andreplaced with an intraocular lens (IOL). As addressed below, cataractlens removal presents addition optical problems and may result inretinal detachment and macular degeneration. This is specifically truefor a myopic patient, and in particular one who is highly myopic.

Intraocular lenses (IOLs) have proven to be very successful in restoringnormal vision to individuals following removal of a natural crystallinelens clouded by the presence of a cataract. The normal human naturallens is thicker in its center than an IOL and this may present a problemwith any patient. In particular, in an individual considered to be ahigh myope (requiring an optical correction greater than about 5diopters) the natural lens may have a thickness as great as 5mm.Following implantation of an IOL the posterior lens capsule wall tendsto shrink and wrap around the IOL. Because of the greater thickness ofthe removed lens, the shrinking capsule can result in the loss ofseveral millimeters of capsule depth, and the remaining posteriorcapsule wall and vitreous fluid shifts forward. This forward movement ofthe vitreous fluid can cause a retinal detachment and initiate maculardegeneration.

This situation was recognized by Giovinazzo in U.S. Pat. No. 4,710,195wherein he states:

-   -   “patients with high myopia are recommended by many to have an        implant lens not for optical correction but to prevent the        mobility of the posterior capsule. This mobility and subsequent        anterior-posterior movement of the vitreous removes many of the        benefits of extra capsular surgery.”

However, IOLs have not been found to adequately prevent the forwardmovement of the rear wall of the capsule.

This problem may be of an even greater concern should the posteriormembrane tear or have to be later removed or opened due to posteriorcapsular opacification (PCO), which is normal in about 30% of IOLplacements. PCO can occur due to the proliferation of epithelial cellsat the periphery of the posterior capsule wall that can grow and spreadunder the IOL on the inside surface of the wall and cause opacification.The normal IOL structure may not be adequate to prevent this PCO.

Lenses have been designed with a ring as part of the rear surface of theIOL in an attempt to prevent opacification and forward movement of thevitreous. U.S. Pat. No. 4,244,060 to Hoffer shows a plano-convexposterior chamber lens with a rearward projecting, substantially annularridge or lip which presses against the rear capsule. The lip is statedto limit “the progress of vitreous humor toward the anterior chamberafter a decision, and may limit lens fiber growth on the posteriorcapsule within the lip region.” Other lens designs are intended toprevent the growth of cells onto the IOL, and thus inhibit posteriorcapsule opacification, by providing a peripheral wall having an outercorner edge with a sharp outer corner resting against the capsule wallto substantially retard or prevent the growth of cells onto the lensside walls and eventually extending across the rear surface of the IOL.

While not specifically designed for high myopes, another approach is toprovide an optic which totally fills the posterior capsules. Oneapproach is shown by Siepser, U.S. Pat. No. 4,556,998 and 5,147,394,which show an expandable hydrogel. A lens of about 2 to 5 mm in diameterand an appropriate thickness is formed from a dry hydrogel. That lens isthen implanted in the posterior capsule where the natural fluids wet thehydrogel which swells to a diameter of 6-14 mm along with an increase inthickness which may fill the depth of the capsule.

A still further alternative is to provide an inflatable lens such asshown in U.S. Pat. No. 4,619,662 to Juergens or U.S. Pat. No. 4,822,360to Deacon. In these designs, an inflatable, transparent sac or bag isplaced in the posterior capsule. The bag is inflated to its intendeddimension by filling with a fluid, which may be a polymerizableelastomer, to create an optically correct, transparent lens with propervision correction. These lenses can be made to fill the posteriorcapsule.

Attempts have also been made to provide special lens designs to meet theoptical requirements of high myopes. These include the use of thickerand greater diameter optics, or lenses with a much greater rearwardangulation. U.S. Pat. No. 3,866,249 to Flom shows a thick biconvex IOLwhich is said to provide support for the hyloid membrane and thevitreous humor.

A further alternative which may be used to provide large opticalcorrections is to implant two lenses in a single eye. The lenses may beseparated from each other by a spacer, or a ring shaped frame may beprovided with a central circular opening to receive a lens of desiredoptical characteristics. This lens insert could also be very thick toprovide telescopic properties. U.S. Pat. No. 5,769,890 to McDonald isdirected to placement of a second IOL, preferably behind the iris but infront of the capsule containing a first IOL, to correct optical errorsresulting from the selection of a first, prior implanted IOL. U.S. Pat.No. 6,616,692 and U.S. Pat. No. 6,797,004 to Brady and Glick also showimplantation of two IOLs, both providing optical correction. The '004patent shows a peripheral holder with the lens centrally located thereinor two optical lenses separated by an intermediate solid spacer tomaintain a preset space between the lenses.

Other examples of peripheral rings to hold an IOL are shown in U.S. Pat.No. 5,628,798 and Published application 2002/0128710 Eggleston, et al.U.S. Pat. No. 6,007,579 to Lipshitz et al shows a telescopic optic heldin a circular ring. U.S. Pat. No. 5,876,442 is a further example of atelescopic optic between two spaced apart carrier rings. Other examplesof the use of a peripheral ring to hold an IOL are U.S. Pat. No.5,824,074 to Koch and U.S. Pat. No. 5,628,795 and RE 34,998 toLangerman. These rings are positioned radially outward from the opticand are used to hold the optic and maintain the diameter of the capsuleor provide accommodation and are not intended to, and do not function,to space the optic rearwardly to maintain the position of the posteriorcapsule wall and the volume of the vitreous chamber.

Also, separate rings have been suggested to maintain the normal capsulediameter. U.S. Pat. No. 5,843,184 shows an example of a tension ringplaced in the capsule solely for the purpose of maintaining the diameterof the capsule and does not hold or space the optic and will notmaintain the capsule volume and vitreous space. Dick discloses the useof a closed, folded, rigid capsular ring inserted prior to IOL Placementto maintain a fixed capsule diameter (Dick, H.B., “Closed FoldableCapsular Rings”, J. Cataract Refract. Surg., 31, pp 467-471 (March2005).

However, none of these devices have proven to be suitable to maintaincapsule depth and vitreous chamber volume and depth unchanged. There istherefore a need for a suitable means for maintaining the shape andvolume of the posterior capsule containing an IOL and the position ofthe rear wall of the capsule in relationship to the rear of the eye, sothe vitreous will not move forward, in turn helping the macula andretina to remain intact. This would be useful in all cataract surgeryand in particularly in aphakic myopics.

SUMMARY

Spacers comprising rings or discs for implantation in the posterior lenscapsule of an individual anterior to an intraocular lens are described.These spacers aid in maintaining the normal depth of the patient'sposterior capsule and to preventing forward movement of the vitreous,and retinal detachment that may occur as a result of such movement. Inaddition, the spacers may have a particular configuration to impede thespread of epithelial cells to reduce or prevent PCO.

BRIEF DESCRIPTION OF DRAWINGS

FIG. 1 is a schematic cutaway side view of the human eye.

FIG. 2 is a schematic cutaway side view showing an IOL located in theposterior capsule of a human eye.

FIG. 3 is a schematic cutaway side view of an IOL placed in theposterior capsule along with spacers incorporating features of theinvention positioned anterior to the IOL.

FIG. 4 is a schematic cutaway side view of an IOL placed in theposterior capsule along with second arrangement of multiple spacerspositioned in the capsule anterior to the IOL.

FIG. 5 is a side perspective view of a disc incorporating features ofthe invention.

FIG. 6 is a side perspective view of a first embodiment ringincorporating features of the invention.

FIG. 7 is a side view of a modification of FIG. 6 showing a ring withangled lower surface cutaway along line 7-7 of FIG. 6 second embodimentof a ring.

FIG. 8 is a cross sectional view of a combination of an IOL, angled ringand disks as it would appear in a posterior capsule.

FIG. 9 is a schematic cutaway view of a further embodiment showing an10L plus multiple spacers.

FIG. 10 is a cross sectional view of a further embodiment of an 10L witha ring and spacer.

DETAILED DESCRIPTION

The structure of the human eye is shown schematically in FIG. 1. Thehuman eye comprises a spherical structure which includes the cornea 100,which comprises the outer surface of the eye, a crystalline lens 102centrally located in a lens capsule 104 behind the pupil 106 and theretina, optic and other nerves 108 on the rear wall of the eye thatconnect the eyes to the brain, and particular areas of the brain thatare in neural communication with the eyes. Images pass through thecornea 100 and iris 110, which is centrally located in the pupil 106,and are focused by the lens 102 onto the image receptors at the rear ofthe eye.

Each eye forms an image upon a vast array of light sensitivephotoreceptors of the retina. The outer cover of the eye, or cornea,protects the lens and acts as a colorless filter to refract light ontothe iris and pupil. The iris 110 corresponds to the aperture in a cameraand contains muscles that alter the size of the pupil to control theamount of light that enters the eye. The natural crystalline lens 102located just behind or posterior to the pupil 106 has a variable shapeunder the indirect control of the peripheral ciliary muscles. Having arefractive index higher than the surrounding media, the crystalline lensgives the eye a variable focal length, allowing accommodation to objectsat varying distances from the eye.

Much of the remainder of the eye is filled with fluids under pressurethat help the eye maintain its shape. For example, the aqueous humor(fluid) 112 fills the anterior chamber 114 between the cornea 100 andthe pupil 106, and the vitreous humor (gel) 116 fills the majority ofthe volume of the eye in the vitreous chamber 118 that is locatedbetween the lens 102 and the retina and other optic nerves 108.

The human eye is susceptible to numerous disorders, diseases and opticaldeficiencies. Corrective glasses, contact lenses or laser sculptingtypically addresses optical deficiencies. Besides optical deficiencies,several diseases that can affect the natural crystalline lens or theoptical nerve 108 or macula 109 can degrade vision. For example,cataracts interfere with vision by causing a cloudy or opaquediscoloration of the natural lens 102 of the eye. Cataracts often resultin partial or complete blindness. If this is the case, as shown in FIG.2 the crystalline lens can be removed and replaced with an intraocularlens (IOL) 16. Cataract lens removal in a myopic patient, particularly ahigh myopic, presents addition optical problems and may result inretinal detachment and macular degeneration.

Intraocular lenses (IOLs) 16 have proven to be very successful inrestoring normal vision to individuals following removal of a naturalcrystalline lens 102 clouded by the presence of a cataract. While thereare many different designs of IOLs and various different placementprocedures, methods for positioning and retaining the IOL in positiononce placed and various different locations for placement of the lens, atypical state of the art IOL 122 is placed within the lens capsule 104(which is a membrane bag enclosing the natural lens 102) after removalof the clouded natural lens. While posterior chamber IOLs 122 may havedifferent shapes and dimensions for the IOL optical portion andperipheral retaining structure, a typical posterior IOL 122 has an opticdiameter of about 6mn and an optic thickness of about 1.5mm thick.

Because a typical lens capsule 104 has a mean diameter of about 10.5mm(range 10.65-12.0mm), the IOL also typically has haptics, flanges orother positioning structure 124 extending outward from the opticalportion 16 of the IOL to keep the optical portion 16 centered within thelens capsule 104 with a central axis generally coinciding with an axisthrough the center of the iris. As shown in FIG. 3, the haptics, flangesor other positioning structure 124 may also be mounted at an angle tothe plane of the optical portion 16 of the IOL 122 so that the opticalportion 16 is pushed rearward against the remaining membrane (referredto as the posterior or hyloid membrane) 126 forming the rear of the lenscapsule 104.

While the normal human natural lens 102 is thicker in its center than anIOL optic 16, this may not present a problem. However, in someindividuals and in particular individuals considered to be a high myopic(requiring an optical correction greater than about 10 diopters) thenatural lens 102 may have a thickness as great as 5mm. Followingimplantation of an IOL 122 the posterior capsule 104 tends to shrink andwrap around the IOL 122. Because of the greater thickness of the removedlens 102, the shrinking capsule can result in the loss of severalmillimeters of capsule 104 depth, the remaining posterior capsule 104shifts forward, aqueous fluid 112 flows from the anterior chamber 114through the iris 110 filling the remaining volume of the capsule 104 andvitreous gel 116 posterior of the capsule membrane 126 may move forward.

The arrows within the eye structure shown in FIG. 2 represent theforward movement of the capsule and the vitreous. This forward movementof the vitreous 116 can cause a retinal detachment 128 and initiatemacular degeneration. However, IOLs 122 have not been found toadequately prevent the forward movement of the rear wall of the capsule.

This problem may be of an even greater concern should the posteriormembrane 126 tear or have to be later opened or removed due to posteriorcapsular opacification, which is normal in about 30% of IOL placements.The lens structure may not be adequate to prevent vitreous 116 fromflowing around the IOL 122 and entering the posterior capsule 104. PCOcan occur due to the proliferation of epithelial cells at the peripheryof the posterior capsule wall that can grow and migrate under the IOL onthe inside surface of the wall and cause opacification. The normal IOLstructure may not be adequate to prevent this PCO.

The invention is directed to devices that can be used to position an IOLmore rearward in the posterior capsule 104 to maintain capsuledimensions such as shown in FIGS. 3, 4 and 8. The devices comprise oneor more spacers which may be in the form of a ring 10, 18 with a centralhole 12 having a diameter 14 approximating that of the IOL optic 16 asshown in FIGS. 6 and 7. The device may also be a disk 20, such as shownin FIG. 5, that covers both the optic 16 and the haptic 124 of the IOL.

The collapse of the enlarged capsule of a high myope following cataractremoval and IOL placement in the capsule is addressed by placement ofone or more transparent rings 10, 18, plates or discs 20 against theanterior face of a posterior chamber IOL 122 and/or the haptic 124thereof. If rings 10, 18 are used, the centrally located open space 12within the ring 10 typically has a diameter 14 approximating thediameter of the IOL optic 16, generally greater then about 6mm, the ring10, 18 being located anterior of the IOL optic 16 and the haptic 124.Alternatively, one or more discs 20 can be stacked on the anteriorsurface of the IOL but still within the capsule 104.

Still further, a combination of discs 20 and rings 10, 18 can be usedsuch as shown in FIGS. 8 and 10. These discs 20 or rings 10, 18 serve asspacers and are not intended to provide any optical correction. Theirprimary purpose is to maintain the normal depth of the capsule 104, pushthe IOL optic 16 rearward so that it makes uniform contact with theposterior membrane 126 of the capsule and maintains the normal locationof the capsule membrane 126 so that the vitreous 116 does not moveforward, which can cause retinal detachment and start maculardegeneration. The ring 10, 18 or disk 20 can also have square edges toact as a barrier to prevent migration of epithelial cells along the backof the IOL 122 and thus prevent or retard posterior capsularopacification.

Since the discs and/or rings push the IOL rearward away from the typicalcentral position for an IOL, the optical correction provided by the IOLmust be adjusted to compensate for the changed position and provide forthe proper optical correction for the patient.

FIG. 5 is a schematic drawing showing an embodiment of a disc 20incorporating features of the invention. FIG. 6 is a schematic drawingshowing a first embodiment of a ring 10 having parallel faces. Thespacers, whether in the form of a disc 20, or ring 10, 18, may beconstructed of numerous biomaterials typically used for ophthalmicimplants including, but not limited to, rigid biocompatible materialssuch as polymethyl methacrylate (PMMA) or polycarbonate or, preferably,deformable materials such as silicone, acrylic or hydrogel polymericmaterials, and the like. If a single spacer (disc 20 or ring 10, 18) isused, a typical spacer would have an outer diameter to match the normaldiameter of the patients capsular bag 104 when enclosing a natural lens102, typically 9.5-13mm, and a thickness of from about 0.5 to about 3mm. If multiple rings 10, 18 or discs 20 are used the thickness of thelargest diameter spacer, which is preferably the spacer contacting theanterior surface of the IOL 122, can be reduced to compensate for thethickness of the other spacers. The other spacers would typically havesmaller diameters so that they form a truncated pyramid when stacked ontop of each other without spaces there between, such as shown in FIGS. 4and 8. While shown in the figures as a planer disc, when implanted theplaner spacer contacting the IOL would preferably contour to the surfaceof the IOL. This would occur without effecting the optical correctionprovided by the IOL. A typical single ring 10, 18 or disc 20 has anouter diameter of about 11-12 mm and a thickness from about 0.5mm toabout 3 mm, but may be thicker if the posterior chamber is unusuallydeep. If multiple discs 20 or rings 10, 18 are used they can havedifferent thicknesses but the total thickness of a stack of discs orrings would chosen to reproduce, in combination with the IOL thickness,the normal depth of the capsular chamber in the patient. Alternatively,as shown in FIG. 9, the spacers can be stacked with the smallestdiameter disc against the 10L or the largest disc may be between smallerdiameter discs. In other words, the various diameter spacers can bestacked so the outer contour of the stack matches the natural internalcontour of the capsule.

When rings are used, it is preferred that the central hole 12 therethrough is equal to or greater than the diameter of the IOL optic 16 sothat the inner edge of the ring 10, 18 is not within the optical path ofan image being observed through the IOL 122 as this can distort theimage and cause glare. Also, because the ring 10 does not directly pushon the optic 16 but instead moves the optic 16 rearward by pressing onthe haptic 124, the ring 18, as best shown in FIG. 7, can also have anangled rear surface, for example matching the angle of the haptic 124from the plane of the optic 16. FIG. 7 shows a ring 18 with an angle tomatch that of an angled haptic 124, typically about 6°.

On the other hand, discs 20 preferably have parallel front and rearsurfaces so that they do not add to or subtract from the opticalcharacteristics of the IOL 122. While they press against the IOL optic16, which may cause the optic 16 to be spaced rearward, the primaryintended function is to also space the haptic 124 rearward, causingrearward movement of the optic 16. For this reason, there is value incombining a ring 10, 18 with a disc 20 and particularly the ring 18 withangled rear surface such as shown in FIGS. 7, 8 and 10.

While multiple discs are shown, the same function can be obtained by useof a single disc and/or ring combination that duplicates theconfiguration of the multiple discs. For example, while FIGS. 4 and 9show three stacked discs, a single disc can provide this configurationwith a stepped edge or a contoured edge that approximates the contour ofthe capsule in which it is to be placed. In the same manner, the ringand two discs shown in FIGS. 8 or 10 can be provided as a single spacerhaving the same or similar outer contour and a posterior opening toreceive the optic of the IOL.

As a further variation, the disc 20 or ring 10, 18 does not have to be asolid material. It can be an inflatable disc 20 or ring 10, 18 that canbe filled with a liquid before or after placement to create the desiredspacer dimensions. This can also provide an opportunity to vary thedimensions of the spacer once implanted by adding or removing the fillermaterial.

As a still further variation, if the disc 20 or ring 10, 18 is flexible,it may also provide accommodation if the zonules in the eye are stillintact, causing the IOL optic 16 to move in response to the eye tryingto focus on images at different distances. While the rings and disc areshown as solid structures, the same spacing effect can be obtained byproving a notch in the disc or a slot across the ring providing anopportunity for the disk to contour more readily to the IOL or the ringdiameter to be increased or decreased after implantation. In suchinstance, to prevent cell migration through the slot of notch it ispreferred to use two or more of the spacers with the notch or slotsoriented in different directions to present a tortuous movement path forthe migrating cells. As a still further alternative, the ring can beprovided with an angled cut 22 through the toroidal portion 24 of thering so that the surfaces along the angled cut can be displaced as thediameter of the ring is increased or decreased. This allows for slightvariation in the ring diameter without providing access for cellmigration.

While the invention may have specific benefit for use in myopic patientswho may have a lens capsule with a greater depth then normal, it is alsocontemplated that the devices shown and described herein can be used inpatients with normal capsule dimensions because IOL lenses are usuallyof a lesser depth (thickness) than the natural crystalline lens whichthe IOL replaces. One skilled in the art will recognize that, based onthe disclosure herein, variations on the construction and shape of thespacers can be made without varying from the invention disclosed hereinand the invention is limited only by the claims set forth below.

1. A device for maintaining the normal depth of a posterior chamber ofthe eye comprising one or more spacers for implantation in a lenscapsule of said individual anterior to a posterior intraocular lensimplanted following removal of a natural crystalline lens, saidposterior intraocular lens comprising an optic portion and optionally ahaptic portion extending from the optic portion, the spacer or at leastone spacer having an outer diameter approximating the diameter of thelens capsule prior to removal of said crystalline lens, the one or morespacers in combination with the intraocular lens producing a depth forthe lens capsule approximating the depth of the lens capsule prior toremoval of said crystalline lens.
 2. The device of claim 1 wherein theone or more spacers are configured to prevent epithelial cell migration.3. The device of claim 1 wherein the one or more spacers comprises oneor more discs, one or more rings, a combination of one or more discs andone or more rings or a single spacer configured to simulate multiplediscs, rings or a combination of multiple discs or rings in a singlestructure.
 4. The device of claim 3 wherein the at least one ring has anopening extending axially at least partially there through, said openinghaving a diameter at least as great as the diameter of the optic portionof said intraocular lens.
 5. The device of claim 3 wherein the at leastone ring has an angled posterior surface, said angled posterior surfacebeing angled to substantially match the angle of the haptic extendingfrom the optic portion of the intraocular lens.
 6. The device of claim 3comprising two or more discs, each disc having a different diameter, thediscs stacked so that the diameter of each disc approximates thediameter of the lens capsule at a location where placed in said capsule,an appropriate diameter disc placed against the anterior surface of theoptic or haptic portion of the intraocular lens.
 7. A device forprevention of forward movement of the vitreous and retinal detachmentfollowing removal of a crystalline lens and placement of a posteriorchamber intraocular lens in a posterior chamber of the eye comprisingone or more spacers sized for implantation in the lens capsule of saidindividual anterior to said posterior intraocular lens, said one or morespacers having a diameter approximating the diameter of the lens capsuleprior to removal of said crystalline lens, the thickness of the one ormore spacers in combination with the thickness of the intraocular lensproducing a depth for the lens capsule approximating the depth of thelens capsule prior to removal of said crystalline lens.
 8. The device ofclaim 7 wherein the one or more spacers are configured to preventepithelial cell migration.
 9. The device of claim 7 wherein the one ormore spacers comprises one or more discs, one or more rings, acombination of one or more discs and one or more rings or a singlespacer configured to simulate multiple discs, rings or a combination ofmultiple discs or rings in a single structure.
 10. The device of claim 9wherein the at least one ring has an opening extending axially at leastpartially there through, said opening having a diameter at least asgreat as the diameter of the optic portion of said intraocular lens. 11.The device of claim 9 wherein the at least one ring has an angledposterior surface, said angled posterior surface being angled tosubstantially match the angle of the haptic extending from the opticportion of the intraocular lens.
 12. The device of claim 9 comprisingtwo or more discs, each disc having a different diameter, the discsstacked so that the diameters thereof progress in accordance with thediameters of the lens capsule, the appropriate diameter disc placedagainst the anterior surface of the optic or haptic portion of theintraocular lens.
 13. The device of claim 1 or 7 wherein the one or morespacers comprise rigid or deformable biocompatible materials.
 14. Thedevice of claim 13 wherein the biocompatible material is a rigidpolymethyl methacrylate or polycarbonate material or a deformablesilicone, acrylic or hydrogel polymer. 15-20. (canceled)